Kelly Services are currently recruiting a Validation Engineer for our Medical Device client in Co. Leitrim.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
- Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845. Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.
- Completion of Validation Programme - Risk Analysis, VMP, IQ's, OQ's, PQ's as required according to procedure QAP 030 and other related procedures.
- Review and Release of batch paperwork for Product release
- Adhere to Plant Safety requirements and Health & Safety requirements relating to your work
- Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
- Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems.
QUALIFICATIONS / EXPERIENCE
- Degree in Engineering/Manufacturing/Quality with emphasis on Medical Devices/Biomedical.
- Ideally 2-3 years previous experience as Quality/Validation Engineer in Medical Device/Pharma Environment.
- Strong attention to detail and problem-solving skills.
- Team orientated with the ability to work on your own initiative
Please apply through the link or contact Niall Curley on 086-4113572 for more information.
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.